Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait
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|ClinicalTrials.gov Identifier: NCT01447316|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : January 17, 2013
|Condition or disease||Intervention/treatment|
|Obesity, Morbid||Other: Subject outcomes following bariatric surgery|
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Impact of Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait and Quality of Life|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Patients undergoing bariatric surgery for weight loss.
Other: Subject outcomes following bariatric surgery
Subject outcomes (body composition, gait analysis, lower extremity joint pain and perceived quality of life) measured at per-op, 2, 4 weeks and 3 months.
- Body Composition, describes change in body composition from pre-op levels [ Time Frame: Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery ]To track changes in body composition and mass during the study, body weight body fat mass, fat free mass will be collected prior to and 2 and 4 weeks after the bariatric surgery using air plethysmography. Air plethysmography (using the BOD POD®) is a reliable technique of body volume and composition, and has been validated for use in obese individuals and is highly correlated to the gold standard of body composition assessment, underwater weighing.
- Gait Analysis, describes change in gait parameters from pre-op levels [ Time Frame: Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery. ]The gait analysis involves walking on a 26' long portable gait mat (GaitRite®). The mat is a cushioned thin mat filled with pressure sensors. Participants will be asked to walk at a self-selected, comfortable pace across the 26 foot long mat. This normal self-selected pace will be performed three times and the values will be averaged for the three trials. The participant will then be asked to walk as quickly as possible across the mat and the velocity to reach 20' will be determined. This will be repeated two more times for a total of 3 trials.
- Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS). [ Time Frame: Describes change in lower extremity joint pain over a period of 3 months; measured with a (VAS) at per-op, 4 weeks and 3 months following surgery ]Joint pain intensity will be self-assessed by a 10 cm (VAS) with terminal descriptors (anchors of 0 cm = no pain; 10 cm = worst possible pain). The (VAS) is an accepted outcome measure for chronic pain.
- Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL) [ Time Frame: Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery ]The (SF36) is an instrument that assesses overall health-related (QOL). The (SF36) is comprised of eight subscales, each ranging from 0-100 points, with higher scores representing better health. The (SF36) has been recommended for use following bariatric surgery to capture meaningful changes in (QOL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447316
|United States, Florida|
|UF&Shands Orthopaedics and Sports Medicine Institute|
|Gainesville, Florida, United States, 32607|
|Principal Investigator:||Heather K Vincent, Ph.D.||University of Florida Department of Orthopaedics and Rehabilitation|